Journal of thrombosis and haemostasis : JTH · 2026
Enoxaparin for the treatment of placenta-derived fetal growth restriction (GROWTH): an open-label multicenter randomized trial.
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Raia-Barjat Tiphaine, Laporte Silvy, Gaucherand Pascal, Huissoud Cyril, Gallot Denis, Merviel Philippe, Hoffmann Pascale, Dupuis Olivier, Giraud Antoine, Zufferey Paul J, Rancon Florence, Presles Emilie, Chauleur Céline
Аннотация
BACKGROUND: The effect of low-molecular-weight heparin, administered from the time of diagnosis of fetal growth restriction (FGR), on fetal growth and birthweight remains uncertain.
OBJECTIVES: To evaluate whether daily enoxaparin, administered from diagnosis of placenta-derived FGR up to 36 weeks of gestation or delivery, reduces the incidence of newborns with a birthweight below the 10th percentile for gestational age.
METHODS: This open-label, randomized, multicenter trial (NCT02672566) included pregnant women with a single fetus (≥22 to <34 weeks) presenting placenta-derived FGR. Participants not requiring anticoagulation were randomly assigned via a web-based system to receive either 4000 IU of enoxaparin once daily with standard care or standard care alone. The primary outcome was the incidence of newborns with a birthweight below the 10th percentile. Secondary outcomes included gestational age at delivery, estimated weekly fetal growth, time to delivery, and perinatal morbidity and mortality.
RESULTS: The study was prematurely discontinued due to insufficient recruitment. From July 2016 to November 2019, 81 participants were enrolled. The incidence of newborns with a birthweight below the 10th percentile did not differ significantly between the enoxaparin group with standard of care (27 of 40, 67.5%) and the standard of care alone group (30 of 41, 73.2%); relative risk, 0.92; 95% CI, 0.69-1.23; P = .63. No significant differences were observed between the groups regarding secondary outcomes or maternal complications.
CONCLUSION: This study found no evidence that daily prophylactic enoxaparin during the antepartum period improves fetal growth or prolongs pregnancy in the context of constituted placenta-derived FGR.
OBJECTIVES: To evaluate whether daily enoxaparin, administered from diagnosis of placenta-derived FGR up to 36 weeks of gestation or delivery, reduces the incidence of newborns with a birthweight below the 10th percentile for gestational age.
METHODS: This open-label, randomized, multicenter trial (NCT02672566) included pregnant women with a single fetus (≥22 to <34 weeks) presenting placenta-derived FGR. Participants not requiring anticoagulation were randomly assigned via a web-based system to receive either 4000 IU of enoxaparin once daily with standard care or standard care alone. The primary outcome was the incidence of newborns with a birthweight below the 10th percentile. Secondary outcomes included gestational age at delivery, estimated weekly fetal growth, time to delivery, and perinatal morbidity and mortality.
RESULTS: The study was prematurely discontinued due to insufficient recruitment. From July 2016 to November 2019, 81 participants were enrolled. The incidence of newborns with a birthweight below the 10th percentile did not differ significantly between the enoxaparin group with standard of care (27 of 40, 67.5%) and the standard of care alone group (30 of 41, 73.2%); relative risk, 0.92; 95% CI, 0.69-1.23; P = .63. No significant differences were observed between the groups regarding secondary outcomes or maternal complications.
CONCLUSION: This study found no evidence that daily prophylactic enoxaparin during the antepartum period improves fetal growth or prolongs pregnancy in the context of constituted placenta-derived FGR.